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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR

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ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ALLURE CRT-P IMPLANTABLE PACEMAKER PULSE GENERATOR Back to Search Results
Model Number PM3140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Heart Failure (2206)
Event Date 07/21/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient got acute left heart failure during the implant procedure. Physician decided to explant the pacemaker and the leads. Rescue measures were given to the patient. Patient's condition was significantly improved and began to return to normal. Patient was stable.
 
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Brand NameQUADRA ALLURE CRT-P
Type of DeviceIMPLANTABLE PACEMAKER PULSE GENERATOR
Manufacturer (Section D)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer (Section G)
ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
15900 valley view court
sylmar CA 91342
Manufacturer Contact
jaime chavez
645 almanor avenue
sunnyvale, CA 94085
8184934022
MDR Report Key5905545
MDR Text Key53061688
Report Number2938836-2016-10528
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
P970013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 07/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/26/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/30/2017
Device Model NumberPM3140
Device Lot NumberS000014648
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/03/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/26/2016 Patient Sequence Number: 1
Treatment
1642T/52, TN126710
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